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Sterility testing

Reliability in the critical steps of the testing process.

Safe and reliable sterility testing

Contamination of samples during mandatory sterility testing of parenteral and other sterile preparations / devices is a potentially costly problem. With tight controls in a well-managed GMP production area, it is perhaps unlikely that the product and samples are contaminated at source. Logically, it is more likely that sample contamination will occur during handling and transport, or in the testing environment. Such "false positive" results create real and extensive costs of extra investigation and retesting. Moreover, products may not be released for sale until such rework is complete with reliable (i.e. negative) results.

Getinge’s sterility testing isolators and patented DPTE® sterile transfer systems provide a safe and sterile self-contained environment for the most critical steps of the testing process.

DPTE® Alpha

The core of the DPTE® transfer system is the Alpha Port, the original Rapid Transfer Port, designed to ensure flexible, optimized and cost-effective production with the highest level of process and patient safety. The DPTE® Alpha Port’s safety interlock and lip seal are rigorously tested to ensure reliable and 100% leak-tight transfer.

DPTE-BetaBag®

A maintenance-free Single-Use transfer solution for an efficient, flexible and scalable manufacturing process. The prefilled bag with components can be sterilized on-site or can be delivered ready-to-use by our different partners.

DPTE® Beta Containers

Available in plastic or stainless steel, reusable DPTE® Beta Containers and inserts give you the flexibility to optimize production according to your precise requirements. Beta Containers allow for safe transfer into and out of a barrier system, across a wide range of life science applications.

Getinge Isoflex-R Isolators

The Getinge Isoflex-R Isolator protects the product against contamination during aseptic operations such as sterility testing. The isolator maintains an enclosed and sterile environment throughout transfer, manipulation, and bio-decontamination.

Glove Leak Testers (GLT)

Transfer Leak Testers (TLT)

Meet current and future regulations with the wireless and pipeless Transfer Leak Tester for DPTE® Alpha ports and rigid Beta parts. Transfer leak tests are performed with a pressure decay method (test in negative pressure), to ensure the highest standards for quality and safety.

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